BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123548 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-15639
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 1, 2012
    Report Date
    April 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15640. IT WAS REPORTED THE PATIENT HAD TURNED HER STIMULATION OFF FOR APPROXIMATELY ONE YEAR DUE TO INADEQUATE PAIN RELIEF. SHE TURNED THE SYSTEM BACK ON AND WAS UNABLE TO FEEL STIMULATION. THE PATIENT DID CHARGER HER IPG DURING THE TIME THE SYSTEM WAS NOT IN USE. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND DIAGNOSTICS INDICATED LOW AND INVALID IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2013 AND THE LEADS HAD MIGRATED AND WERE WRAPPED AROUND THE IPG. THE PHYSICIAN REVISED THE LEADS AND THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218605 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3157342

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: